A Study for the Participants With Metastatic Hormone Sensitive Prostate Cancer (mHSPC) Treated With Androgen Deprivation Therapy (ADT) Plus Apalutamide or Enzalutamide
- Conditions
- Metastatic Hormone-sensitive Prostate Cancer
- Interventions
- Registration Number
- NCT05901649
- Lead Sponsor
- Janssen-Cilag Ltd.
- Brief Summary
The purpose of this study is to assess the real-world outcomes differences between apalutamide or enzalutamide plus androgen deprivation therapy (ADT) for the treatment of participants with metastatic hormone-sensitive prostate cancer (mHSPC).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 450
- Must have a histologically or cytologically-confirmed diagnosis of adenocarcinoma of the prostate
- Must have documented metastatic hormone-sensitive prostate cancer (mHSPC)
- Must have agreed with the treating physician the initiation of either apalutamide or enzalutamide (plus androgen deprivation therapy [ADT]) treatment, per the treating physician's decision, prior to enrollment into the study
- Must sign, and/or their legally acceptable representative where applicable must sign, a participation agreement/ informed consent form (ICF) allowing data collection and source data verification in accordance with local requirements
- Must have baseline prostate-specific antigen (PSA) captured within 30 days prior to the first administration of apalutamide or enzalutamide
- Must agree to complete patient-reported outcomes (PROs) during the study, including the baseline ones collected before the first administration of apalutamide or enzalutamide
- Has already received or is currently receiving either apalutamide or enzalutamide, or any other novel hormonal treatments (including but not limited to abiraterone acetate and darolutamide)
- Is currently receiving an active treatment for prostate cancer as part of an interventional study
- Has a progression under ADT treatment (and thus became castrate-resistant) prior to start of apalutamide or enzalutamide treatment
- Has received ADT treatment for mHSPC for more than 2 months prior to apalutamide or enzalutamide treatment initiation or ADT treatment was administered for earlier disease stages within the last 12 months prior to apalutamide or enzalutamide treatment initiation
- Has received prior docetaxel for the treatment of mHSPC
- Participants is not treated in line with current Summary of Product Characteristics for apalutamide or enzalutamide
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Apalutamide Plus Androgen Deprivation Therapy (ADT) Apalutamide Participants with metastatic hormone-sensitive prostate cancer (mHSPC) will be observed who are being treated with apalutamide under clinical practice setting. Only data available per routine clinical practice will be collected within this study. Enzalutamide Plus Androgen Deprivation Therapy (ADT) Enzalutamide Participants with metastatic hormone-sensitive prostate cancer (mHSPC) will be observed who are being treated with enzalutamide under clinical practice setting. Only data available per routine clinical practice will be collected within this study.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Prostate-specific Antigen (PSA) Level <0.2 ng/mL at Month 3 At month 3 Percentage of participants with PSA level less than (\<)0.2 nanogram per milliliter (ng/mL) at month 3 will be reported.
Cognitive Functioning as Assessed by Partial Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog) Questionnaire Up to 30 Months Cognitive function of the participants will be measured by the partial FACT-Cog (Version 3) questionnaire. The FACT-Cog score ranges from scale 0-148. The higher the total score, the better the cognitive function.
Health-Related Quality of Life (HRQoL) as Assessed by Partial European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) Questionnaire Up to 30 Months HRQoL of the participants will be assessed as partial EORTC QLQ-C30 questionnaire. EORTC QLQ-C30 scale scores range from 0 to 100. A high score for a functional scale represents a high level of functioning, whereas a high score for a symptom scale/single item represents a high level of symptom.
Fatigue as Assessed by Brief Fatigue Inventory-Short Form (BFI-SF) Questionnaire Up to 30 Months Participant fatigue will be assessed by the BFI-SF questionnaire. The BFI-SF score range from scale 0-10. Scores are categorized as Mild (1-3), Moderate (4-6), and Severe (7-10).
Prostate-specific Antigen (PSA) Anxiety as Assessed by Memorial Anxiety Scale for Prostate Cancer (MAX-PC) Questionnaire Up to 30 Months PSA anxiety of the participant will be assessed by the MAX-PC questionnaire. The MAX-PC total score ranges from scale 0 to 54. The MAX-PC is divided into three subscales: a) prostate cancer anxiety (PCA) range from 0 to 33, b) Prostate-Specific Antigen Anxiety (PSAA) ranges from 0 to 9, and c) fear of recurrence (FOR) ranges from 0 to 12.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (53)
Alexandra General Hospital of Athens
🇬🇷Athina, Greece
Hosp Univ A Coruna
🇪🇸A Coruna, Spain
Hosp. Univ. de Canarias
🇪🇸La Laguna, Spain
Royal Cornwall Hospitals NHS Trust - Royal Cornwall Hospital
🇬🇧Cornwall, United Kingdom
Torbay Hospital-Devon
🇬🇧Devon, United Kingdom
Dorset County Hospital Nhs Foundation Trust
🇬🇧Dorchester, United Kingdom
Royal Surrey County Hospital NHS Trust
🇬🇧Guildford, United Kingdom
University College London Hospitals Nhs Foundation Trust
🇬🇧London, United Kingdom
Royal Free London NHS Foundation Trust
🇬🇧London, United Kingdom
Pennine Care Nhs Foundation Trust
🇬🇧Oldham, United Kingdom
Scunthorpe General Hospital
🇬🇧Scunthorpe, United Kingdom
Taunton and Somerset NHS Foundation Trust
🇬🇧Taunton, United Kingdom
University Hospitals Sussex NHS Foundation Trust Worthing Hospital
🇬🇧Worthing, United Kingdom
CHU Nimes
🇫🇷Nimes, France
Klinikum Wels Grieskirchen
🇦🇹Wels, Austria
Hopital Europeen Georges-Pompidou
🇫🇷Paris, France
St. Elisabeth Hospital Leipzig
🇩🇪Dresden, Germany
Urologicum Duisburg
🇩🇪Duisburg, Germany
Krankenhaus Barmherzige Brüder Regensburg
🇩🇪Regensburg, Germany
Attikon University General Hospital of Attica
🇬🇷Athens, Greece
Akh Wien
🇦🇹Wien, Austria
Clinique Pasteur- Lanroze
🇫🇷Brest, France
Institut Bergonie
🇫🇷Bordeaux, France
Polyclinique Bordeaux Nord Acquitaine
🇫🇷Bordeaux, France
Hopital Michallon CHU Grenoble Alpes
🇫🇷La Tronche, France
Hopital Tenon
🇫🇷Paris, France
Hopital Foch
🇫🇷Suresnes, France
Universitaetsklinikum Muenster
🇩🇪Muenster, Germany
Anticancer Oncology Hospital of Athens Agios Savvas
🇬🇷Athens, Greece
University General Hospital of Rio Patras
🇬🇷Patras, Greece
Hosp. Univ. Lucus Augusti
🇪🇸Lugo, Spain
Hosp Regional Univ de Malaga
🇪🇸Malaga, Spain
Urologisches Zentrum Mittelhessen
🇩🇪Gladenbach, Germany
Centre Hospitalier Rene Dubos Pontoise
🇫🇷Pontoise, France
Centre Hospitalier Prive
🇫🇷Saint-Grégoire, France
Urologie Dierdorf
🇩🇪Dierdorf, Germany
University Hospital of Heraklion
🇬🇷Heraklion, Greece
Hosp. Torrecardenas
🇪🇸AlmerÃa, Spain
Hosp. Puerta Del Mar
🇪🇸Cádiz, Spain
Institut Sainte Catherine
🇫🇷Avignon, France
Hôpital Edouard Herriot
🇫🇷Lyon, France
Centre d'oncologie de Gentilly
🇫🇷Nancy, France
CHU de Toulouse
🇫🇷Toulouse cedex 9, France
Universitatsmedizin der Johannes Gutenberg Universitat Mainz
🇩🇪Mainz, Germany
General Oncology Hospital of Kifisias "Agioi Anargyroi
🇬🇷Athens, Greece
Papageorgiou General Hospital Of Thessaloniki
🇬🇷Thessaloniki, Greece
Hosp. Gral. Univ. de Castellon
🇪🇸Castellon, Spain
Clinique de la Croix du Sud
🇫🇷Quint-Fonsegrives, France
Clinique Sainte Anne
🇫🇷Strasbourg, France
Praxis Dr. Serkan Filiz
🇩🇪Hamburg, Germany
Hosp. Clinico Univ. de Santiago
🇪🇸Santiago de Compostela, Spain
Hosp. Univ. I Politecni La Fe
🇪🇸Valencia, Spain
Frimley Health NHS Foundation Trust
🇬🇧Berkshire, United Kingdom